FDA expects IV saline, amino acid supplies to increase in coming weeks

Intravenous saline and amino acid drug supplies should begin to increase in the next few weeks as manufacturing facilities in Puerto Rico ramp up production, Food and Drug Administration Commissioner Scott Gottlieb, M.D., said yesterday in an update on the shortages. “Just before the holidays, Baxter – a leading producer of IV saline fluids – announced that all their facilities on the island have returned to the commercial power grid,” Gottlieb said. “Moreover, all the other companies that manufacture products that were on our initial list of drugs that we considered critical and at risk of potential shortages – because the drugs were largely or entirely manufactured in Puerto Rico – are now on the power grid. Many of these companies report to us that their production is increasing. While there are still many challenges that remain – for instance, the commercial power grid remains unstable in places – these developments reduce the risk of any future shortages resulting from the impact of the storm on the island’s manufacturing sector.” AHA has urged FDA and Congress to do more to address the drug shortages, and worked with FDA and the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response to update members on the issue.